Drugs
FDA has approved Eli Lilly’s Taltz (ixekizumab) injection 80 mg/mL for treating adults with active ankylosing spondylitis (AS), also known as radiographic axial spondyloarthritis. The drug was initially approved 3/2016 for treating moderate to severe plaque psoriasis in adult patients who are candidates for systemic therapy or
Drugs
FDA commissioner Ned Sharpless says that it plans to release a final guidance on developing amyotrophic lateral sclerosis (ALS) drugs and biologics products by the end of September. “Patients are at the forefront of everything we do, and FDA remains deeply committed to supporting the (ALS) community in its efforts
Drugs
A new report from FDA says that from 4/1/1999 to 8/31/2018 there were 548 orphan indications approved. Of these, FDA identified 200 orphan indications that did not warrant pediatric labeling (adult only indications or indications for which pediatric studies were impossible or highly impracticable). “Of the
Drugs
FDA wants to start seeing more males included in breast cancer drug trials and using real world data can help. A draft guidance, Male Breast Cancer: Developing Drugs for Treatment, has been released that provides recommendations on how additional data to support efficacy and safety for male patients with breast
Drugs
FDA has approved an Akorn ANDA for azelastine hydrochloride nasal spray, 0.15%, indicated for relieving symptoms of seasonal allergic rhinitis and perennial allergic rhinitis in patients six years of age and older. U.S. annual sales of azelastine hydrochloride nasal spray are about $18 million. The product will be
Drugs
Oklahoma county judge Thad Balkman ruled 8/26 against Johnson & Johnson in the state’s opioid trial, saying the company must pay $572 million in the first ruling in the U.S. holding a drugmaker responsible for helping fuel the opioid epidemic. The judge called the opioid crisis an
Drugs
Medline has recalled its Primary Warmer Pack because it contains the recalled Vyaire Medical enFlow Disposable Cartridge, “which may elute aluminum into infused fluids during use, potentially exposing patients to unsafe aluminum levels,” according to a recall notice. “Continued use of these products may result in prolonged, undetected aluminum exposure
Drugs
Former FDA commissioner Robert Califf says the current concern over the inclusion of faulty data in Novartis’ BLA for Zolgensma (onasemnogene abeparvovec-xioi), a novel gene therapy indicated to treat spinal muscular atrophy in children at a cost of $2.1 million for a single, one-time dose, raises questions
Drugs
Altaire Pharmaceuticals has recalled several veterinary ophthalmic drug products due to concerns about quality assurance controls at its manufacturing facility. To date, Altaire says it has not received any adverse event reports associated with the recalled products. According to a recall notice, the products are manufactured and labeled exclusively for
Drugs
An 8/16-8/22 FDA inspection at the Alkem Laboratories drug manufacturing facility at Fenton, MO, resulted in issuance of an FDA-483 with four inspection observations, according to an online Equity Bulls post. The agency also inspected the company’s Baddi, India, manufacturing facility from 8/19 to
Drugs
Attorneys Khelin Aiken and Anisa Mohanty (McDermott Will & Emery) review the FDA proposal to modernize new drug development as authorized by the 21st Century Cures Act. The agency’s 2018 initial proposal, they write in an online post, covered: * focusing on recruiting talent across disciplines; * building multidisciplinary teams for
Drugs
The Bipartisan Policy Center, which includes former FDA commissioners Robert Califf, Andrew von Eschenbach, and Mark McClellan on its leadership team, has issued a report with recommendations for expanding the use of real-world evidence (RWE) in regulatory and value-based payment decision-making for drugs and biologics. In an
Drugs
Indian drug companies received one-third (13) of the 38 FDA Warning Letters issued as of 8/21, according to an analysis by the print and online environmental publication Down to Earth. U.S. companies received 15 of the letters. “The reason for such high number of Warning Letters to
Drugs
FDA has accepted for priority review a BeiGene NDA for zanubrutinib for treating patients with mantle cell lymphoma (MCL) who have received at least one prior therapy. The submission includes data from a global Phase 1/2 trial (NCT02343120) in patients with B-cell lymphomas and an aggregate of 123
Drugs
Shilpa Medicare, an active pharmaceutical ingredients (API) manufacturer in Karnataka, India, has been issued a five-observation Form FDA-483 after an inspection concluded 7/26. According to the form, FDA cited Shilpa for failing to thoroughly review any unexplained discrepancy and the failure of a batch or any of
Drugs
Some 21 medical organizations and professional societies led by the American Medical Association are expressing concern that actions taken by FDA in finalizing compounding-related guidance documents “may significantly hinder our physicians’ ability to provide critical treatments to patients in office settings.” The 8/13 letter says an updated 9/
Drugs
President Donald Trump has told the Department of Veterans Affairs to purchase “a lot” of Johnson & Johnson’s Spravato (esketamine) to help fight veteran suicides. Trump told reporters about the purchase 8/21 as he prepared to go to a national veterans conference in Kentucky. The McClatchy news service
Drugs
After two decades of actual use of mifepristone to end early unwanted pregnancies, additional research, and a comprehensive review by the National Academies of Science, Engineering, and Medicines, there may no longer be a need for the distribution restrictions that were imposed when the drug was first approved in 2000.
Drugs
Regeneron is commenting on an FDA draft guidance on drug development endpoints for treating heart failure “to assist the agency in enhancing the clarity of the recommendations provided to industry and key stakeholders. We believe these clarifications will strengthen guidance on the appropriate endpoints to include in heart failure clinical
Drugs
An Avoca Group white paper defines and describes a risk-based approach to clinical trial inspection readiness, based on activities related to risk-based quality management (RBQM). The paper says RBQM is a “systematic process put in place to identify, assess, control, communicate, and review the risks associated with the
Drugs
FDA has released an updated version of the Clinical Outcome Assessment (COA) Compendium “to encourage development and implementation of patient-focused clinical outcome assessments in clinical trials to support drug approvals and labeling claims. The agency says the compendium is a communication tool that organizes and summarizes COA information for
Drugs
Selectively sharing information with stock analysts and not through open public disclosures after meeting with FDA on a product development issue is a “no-no.” So learns TherapeuticsMD, a pharmaceutical company headquartered in Boca Raton, FL, after being charged by the Securities and Exchange Commission (SEC) 8/20. According to